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First Human Study of HIV Vaccine Vacc-C5 to beginOslo 29.05.2012 - Animal Studies Indicate Similar Generation of Immune Responses as Those in HIV Patients who Naturally Suppress the Infection

News Summary

Open, clinical study, dose escalating, phase I/II, with Bionor Pharma`s second therapeutic HIV vaccine to begin at Oslo University Hospital.Researchers hope Vacc-C5 will prevent hyperactivation of immune system that leads to AIDS, and possibly thereby make patients able to control HIV replication without the need for medication.The study will investigate whether humans develop antibodies to HIV as a result of vaccination with Vacc-C5, and if these antibodies have same properties as antibodies found in “long term non progressors,” in other words patients who live with HIV but are able to naturally suppress the virus.Bionor Pharma ASA announced today that the first study of Bionor Pharma’s Vacc-C5 is now approved to begin at Oslo University Hospital. Vacc-C5 is a therapeutic HIV vaccine developed to slow down or stop induction of immune hyperactivation, a feature that drives the production of HIV and is damaging the immune system, leading to AIDS. Vacc-C5 also may have the potential to be a preventive vaccine, alone or in combination with Vacc-4x.

The phase I/II study will use Vacc-C5 at three different dose levels, in order to evaluate safety and provide a determination for the optimal dose of the vaccine, when given intradermally (in the skin) or intramuscularly.

“The pre-clinical studies of Vacc-C5 in rabbits, and sheep, as well as data confirming an association between high antibody levels and slow progression of HIV in humans have generated considerable interest,” said Dag Kvale, MD, PhD, Principal Investigator at Oslo University Hospital. “We look forward to see how people living with HIV respond when on Vacc-C5.”

The study seeks to recruit 36 patients who have been infected with HIV for at least one year. Study participants must have been stable on antiretroviral therapy (ART, traditional HIV medicine) for at least six months with a viral load of less than 50 copies per milliliter. The primary endpoint of the trial is to evaluate safety of the vaccine at three different dose levels. Secondary endpoints include measuring specific antibody and T-cell responses to Vacc-C5 and to evaluate T-cell activation markers. Vacc-C5 will be given in combination with two different adjuvants, (that enhance the immune response), either GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) or Alhydrogel (an aluminum-based treatment).

Why is the study dubious just because they did some pre-clinical trials on rabbit and sheep? These are also mammals, just as mice and humans. And they don't say what kind of tests they did exactly. I am pretty sure that the development of the vaccine itself, however, took place with the use of mice.

I have a background in molecular biology, though neither immunology nor HIV are my areas of expertise.

This study looks very promising to me. Clinical trials are expensive. They wouldn't do it if they don't believe in their vaccine. (In contrast, what I find dubious are startups, that have published one paper in a mediocre journal, claim to have the solution for the cure and are now looking for investors.)The other vaccine Bionor is developing, Vacc-4x, has already shown to be effective in reducing viral loads (but it was only a small-scale trial). So, this gives me confidence that they are on the right track.If they succeed, one day we could stop taking pills every day and instead get this therapeutic vaccine once or twice a year to remain UD. Also, it shouldn't have side effects like the other drugs, since it's just antibodies.

Why is the study dubious just because they did some pre-clinical trials on rabbit and sheep? These are also mammals, just as mice and humans. And they don't say what kind of tests they did exactly. I am pretty sure that the development of the vaccine itself, however, took place with the use of mice.

I have a background in molecular biology, though neither immunology nor HIV are my areas of expertise.

This study looks very promising to me. Clinical trials are expensive. They wouldn't do it if they don't believe in their vaccine. (In contrast, what I find dubious are startups, that have published one paper in a mediocre journal, claim to have the solution for the cure and are now looking for investors.)The other vaccine Bionor is developing, Vacc-4x, has already shown to be effective in reducing viral loads (but it was only a small-scale trial). So, this gives me confidence that they are on the right track.If they succeed, one day we could stop taking pills every day and instead get this therapeutic vaccine once or twice a year to remain UD. Also, it shouldn't have side effects like the other drugs, since it's just antibodies.

Personally I'm not waiting for a vaccine. It seems such a sophisticated solution for our current medical scenario. They can't even come up with a vaccine for, I don't know, herpes! for God's sake...I'm skeptic.

I'm more hopeful for some new medication that you don't have to take every day, for instance.

Personally I'm not waiting for a vaccine. It seems such a sophisticated solution for our current medical scenario. They can't even come up with a vaccine for, I don't know, herpes! for God's sake...I'm skeptic.

I'm more hopeful for some new medication that you don't have to take every day, for instance.

"Here, just once a week and you'll be fine".

That would be pretty awesome indeed.

I honestly thought the same thing. - BUT I remember my doctor said "By age forty, 90% of people have herpes virus in their system" Yet most majority live on to old ripe age. (I don't know what type of herpes, but I assume the typical mouth sores type aka. from stress flareups.)

Another promising scandinavian company is FIT Biotech from Finland. A trial in South Africa was quite good:

"The FIT vaccine comprises a combination of gene fragments designed to make the patient immune to six viral proteins. In around 80% of patients receiving treatment, the virus was suppressed and CD4+ levels were maintained two years after therapy began." Source: http://www.nature.com/news/2010/100727/full/466539a.html

The study finally began last Tuesday. I received my first vaccine injection. I will receive another 4 shots within next 26 weeks. They are doing blood work each week and I will post the results when I get them

The study finally began last Tuesday. I received my first vaccine injection. I will receive another 4 shots within next 26 weeks. They are doing blood work each week and I will post the results when I get them

I am still on Atripla. No changes there. The plan is to receive two injections each 6 weeks until April 2013. The trial will be finished sometimes in May. Next week they will take the first blood work to evaluate the effect of the first two injections.

First, I am by no means a biologist and not familiar with this study beyond reading the press release. However, based on my understanding the goals of the trial are to evaluate the safety of the vaccine and to see if the immune system responds (making more antibodies and T-cells of a specific kind). Here is a quote from the new release:

"The primary endpoint of the trial is to evaluate safety of the vaccine at three different dose levels. Secondary endpoints include measuring specific antibody and T-cell responses to Vacc-C5 and to evaluate T-cell activation markers."

They will look for a statistical difference of these endpoints between the group that receives the vaccine and the group that receives the placebo. Technically, they are not expecting or looking for a change in viral load - and a statistically significant change in these endpoints should be seen even if the participants are on meds. Realistically, they will look for changes in any piece of data (including viral load) that they have, but they are not expecting to see a change in viral load.

If they can demonstrate safety, and there is a statistically significant increase in the right kind of antibodies and T-cells, then they would likely go to another Phase II trial (perhaps in combination with Vacc-4x?), then a Phase III trial would need to be done. The point is that we are at least a few more trials away before we know if this really works.

While this is going to take some time, each step in the process is very important - and I really appreciate hubsen's participation in this trial.

I had my 4th injection on December 6th. Next boost (4 of them) will be administrated on January 22nd with 2 weeks in between. So far I feel great. I will know the results of my blood work on the 22nd - I will post then. Happy New Year!!!

I had my 4th injection on December 6th. Next boost (4 of them) will be administrated on January 22nd with 2 weeks in between. So far I feel great. I will know the results of my blood work on the 22nd - I will post then. Happy New Year!!!

Hey Hubsen -- thanks for posting all of this... and congrats on the rising T-Cells. They can bounce around a lot but it's always good when the bounce is up!

So, they're going to be looking for ABs in the blood work? That would make sense. Somewhere on this board is the thread about the two guys that had stem cell transplants while on meds. They're ABs are declining, which is suggesting that the stem cell transplants may have cured them (the transplants were NOT from non-CCR5 donors, which is interesting). I'm assuming that they are looking at the same measure (declining ABs, hopefully) in you.

Hi everyone, As mentioned this is a phase I trial - primarily to decide and secure the dose of the vaccine. My doctor will tell me more about the outcome once the trial is finished (sometimes in May this year). So far it is a very promising treatment method with minimal side effects. According to the blood work results - the vaccine is probably showing to be effective.

The time is too short to tell if it brigs the desired effect or not.

I received 3rd round (2 vaccines in 2 weeks) couple of weeks ago and blood work test were taken last Tuesday. I will post the update as soon as I know..

good luck and please keep us updated with Your results. Do U live in Norway? As far as I know the Vacc-C5 is tested only in Oslo. I think Bionor Immuno has the most promising therapeuthic vaccines in the pipeline. I think over to be part in a Vacc-4x trial, but i dont know yet, I'm a bit scared.